CN118251249A - Component for a drug delivery device and drug delivery device - Google Patents

Abstract

A component for a drug delivery device and a drug delivery device. The invention relates to a component (2) for a drug delivery device (100) configured to be connected to an arrangement (2) of drug delivery devices and comprising functional elements (21, …, 25). At least when the component is connected to the arrangement, a transition region (3) is formed between facing surfaces of elements of the drug delivery device, wherein at least one of the elements is an element of the component. The transition region reaches from the outside of the component to the inside of the component and is designed such that the risk of fluid reaching from the outside to the inside of the component via the transition region is reduced in order to protect the functional element.

Description

Component for a drug delivery device and drug delivery device

Technical Field

A component for a drug delivery device is provided. Furthermore, a drug delivery device is provided.

Background

Administering injections is a process that creates many risks and challenges for both the user and the healthcare professional, both mental and physical. The goal of the drug delivery device may be to make self-injection easier for the patient. Drug delivery devices using electronics are becoming increasingly popular in the pharmaceutical industry and for users or patients. To ensure proper operation of the drug delivery device, stable operation of the electronic components is desirable.

Disclosure of Invention

It is an object to be achieved to provide an improved component for a drug delivery device. Preferably, the component may enable stable operation of the drug delivery device. A further object to be achieved is to provide an improved drug delivery device.

These objects are achieved, inter alia, by the subject matter of the independent claims. Advantageous embodiments and further developments are the subject matter of the dependent claims and are also presented in the following description and the figures.

First, this component will be described in detail. The means may be a user interface member, such as a button and/or knob, for a user to operate and/or activate the drug delivery device. The component may also be a module of the drug delivery device that is not operated by the user.

According to at least one embodiment, the component is configured to be connected to an arrangement of drug delivery devices. For example, the component is configured to be permanently connected to the arrangement or releasably connected to the arrangement. For example, the component is configured to be disposed at a proximal end of the arrangement. When connected to the arrangement, the component may form the proximal end of the drug delivery device.

The arrangement may comprise a medicament container holder for holding a medicament container filled with medicament. The arrangement may comprise a drive mechanism for delivering a medicament and/or a dose setting mechanism for dialing a dose of the medicament. The mechanism(s) may comprise a drive element such as a plunger rod and/or a drive sleeve and/or a dial sleeve. The drive element is for example operatively coupled for axially and/or rotationally moving the plunger rod and/or the drive sleeve and/or the dial sleeve for delivering a medicament and/or a dial medicament dose.

The component may be connectable to the arrangement, for example such that the component is operably coupled to a drive mechanism and/or a dose dial or set mechanism. When coupled to the arrangement, the component may be movable, e.g. rotatable and/or axially movable, with respect to at least one element of the arrangement (e.g. a medicament container holder).

According to at least one embodiment, the component comprises at least one functional element. The functional element may be associated in particular with an electrical or electronic function of the component and/or with a mechanical function of the component. The functional element may be arranged in the interior of the component. For example, the functional element may be hidden behind the component and/or one or more housing elements of the arrangement, at least when connected to the arrangement. For example, the functional element may then not be freely accessible and/or visible from the outside of the drug delivery device.

According to at least one embodiment, a transition region is formed between facing surfaces of the elements of the drug delivery device at least when the component is connected to the arrangement. At least one of these elements may be an element of the component, such as a housing element of the component.

The transition region may be formed between two or more elements, for example three or more elements of the drug delivery device. All of these elements may be elements of the component such that the component itself comprises a transition region, or one or more of the elements defining a transition region may be elements of the arrangement. These elements forming the transition region therebetween may each be formed in one piece and/or may be formed from plastic. In particular, these elements are separate elements, i.e. they are not integrally formed in one piece.

The transition region is formed between the surfaces facing each other. These surfaces may extend at least partially parallel to each other. The surfaces may be spaced apart from each other such that a gap is formed between the elements. Alternatively, the surfaces may contact each other such that an interface is formed between the elements.

According to at least one embodiment, the transition region reaches from the outside of the component to the inside of the component, in particular from the outside surface of the component to the inside surface of the component, wherein the inside surface adjoins the inside. In particular, the gap and/or the interface may reach from the outside to the inside. For example, the transition region may be accessible and/or visible from the exterior of the component. The interior of the component is in particular circumferentially surrounded by at least one housing element of the component. This means that the interior can be delimited in the outward radial direction by at least one housing element of the component.

In this context, the "exterior of a component" may be a space or region outside of a housing element of the component. The "exterior of the component" may be a space or area inside the housing of the drug delivery device. Alternatively or additionally, the "exterior of the component" may be a space or area outside the housing of the drug delivery device.

In this context, an "outer surface of a component" may be a surface of the component whose surface normal does not pass through another surface of the component.

According to at least one embodiment, the transition region is designed such that the risk of fluid passing from the outside to the inside of the component via the transition region is reduced in order to protect the functional element. The fluid may be in liquid form or in gaseous form. The fluid may be water or a drug of the drug delivery device.

The length of the transition zone measured from the outside to the inside of the component may be at least 1mm or at least 1.5mm or at least 2mm.

For example, there may be two or more transition regions in the component or at least when the component is connected to the arrangement. All features disclosed in connection with one transition region are also disclosed for the other transition region.

In at least one embodiment, the means for the drug delivery device is configured to be connected to an arrangement of drug delivery devices and comprises a functional element. At least when the component is connected to the arrangement, a transition region is formed between facing surfaces of elements of the drug delivery device, wherein at least one of the elements is an element of the component. The transition region reaches from the outside of the component to the inside of the component and is designed such that the risk of fluid reaching from the outside to the inside of the component via the transition region is reduced in order to protect the functional element.

Fluid reaching functional elements (i.e., particular elements associated with the electrical or electronic function of the component) may affect the function of those elements. For a component configured to be connected to an arrangement, particularly when the component is arranged to be movable relative to at least one element, the arrangement creates a transition region between one or more elements of the component and one or more elements of the arrangement, the transition region reaching from outside to inside the component. However, such a transition region is a region through which fluid may pass from the exterior to the interior of the component.

Furthermore, a transition region may be formed between elements of the component. For example, during the manufacture of a component, it may be necessary to physically connect to a functional element, for example, to program, calibrate, configure and/or check its function. Such a functional element may be located after a cover element of the component added at the end of manufacture. However, a transition region is then formed between this cover element and the other housing element of the component, through which transition region fluid may again enter the interior of the component.

By designing the transition region between the elements such that the risk of fluid passing from the outside to the inside via the transition region is reduced, in particular damage to the functional elements of these components can be reduced. Different ways of reducing this risk are possible and are further described below.

The components and/or drug delivery devices detailed herein may be elongate and/or may include a longitudinal axis, such as a main extension axis. Additionally or alternatively, the component and/or the drug delivery device may be rotationally symmetrical about the longitudinal axis. The direction parallel to the longitudinal axis is referred to herein as the axial direction. For example, the drug delivery device and/or the component may be cylindrical.

Furthermore, the drug delivery device may comprise an end, e.g. a longitudinal end, which may be arranged to face or be pressed against a skin area of the human body. This end is referred to herein as the distal end. The drug or medicament may be supplied via the distal end. The opposite end is referred to herein as the proximal end. During use, the proximal end is remote from the skin area. The axial direction from the proximal end to the distal end is referred to herein as the distal direction. The axial direction from the distal end to the proximal end is referred to herein as the proximal direction. The distal end of a member or element or feature of a drug delivery device (e.g., component) is herein understood to be the end of the member/element/feature that is located furthest distally. Thus, the proximal end of a member or element or feature is herein understood to be the end of the element/member/feature that is located most proximally.

In other words, distal is used herein to designate a direction, end or surface arranged or to be arranged facing or directed towards the dispensing end of the drug delivery device or a component thereof and/or facing away from, to be arranged facing away from, or facing away from the proximal end. In another aspect, proximal is used herein to designate a direction, end or surface arranged or to be arranged away from or facing away from the dispensing end and/or distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dispensing end and/or the end furthest from the proximal end, and the proximal end may be the end furthest from the dispensing end. The proximal surface may face away from the distal end and/or face toward the proximal end, and the distal surface may face toward the distal end and/or face away from the proximal end. For example, the dispensing end may be a needle end at which the needle unit is mounted or is to be mounted to the device.

The direction perpendicular to and/or intersecting the longitudinal axis is referred to herein as the radial direction. The inward radial direction is a radial direction pointing towards the longitudinal axis. The outward radial direction is a radial direction facing away from the longitudinal axis. The terms "angular direction", "azimuthal direction" or "rotational direction" are used synonymously herein. Such a direction is a direction perpendicular to the longitudinal axis and perpendicular to the radial direction.

According to at least one embodiment, the transition region is a fluid path transition region in which the facing surfaces are spaced apart from each other such that the fluid path extends between the surfaces. The fluid may travel along this fluid path. In particular, the fluid path may reach from the outside of the component to the inside of the component, for example up to the functional element.

In particular, the transition region includes gaps or spaces between elements defining the transition region. The gap may extend uninterrupted from the exterior of the component to the interior of the component. The fluid path may extend in this gap. For example, the minimum height or width of the gap measured between the facing surfaces of the elements is at least 0.05mm, 0.1mm or 0.2mm. Additionally or alternatively, the maximum height or width of the gap is at most 1.5mm, 1mm, 0.5mm, 0.4mm or 0.3mm.

According to at least one embodiment, the transition region is designed such that, within the transition region, the fluid path comprises two sections extending in different axial directions. This means that the fluid (e.g. water or a drug) flowing in the device in the transition region along the fluid path from the outside to the inside has to change its flow direction from one axial direction to the opposite axial direction. For example, a section extending in the proximal direction follows a section extending in the distal direction when following an external to internal fluid path within the transition region. The sections extending in different axial directions may extend at least partially parallel to each other. The two sections of the fluid path may be radially offset from each other. For example, the section extending in the proximal direction may be offset radially inward relative to the section extending in the distal direction.

For example, the length of each of the two sections along the axial direction is at least 2mm or at least 5mm. Additionally or alternatively, the length of the sections along the axial direction may be at most 1cm or at most 5mm.

According to at least one embodiment, the length of the fluid path is at least 1mm or at least 2mm or at least 7mm or at least 8mm or at least 9mm or at least 10mm. Alternatively or additionally, the length of the fluid path may be at most 20mm or at most 18mm or at most 15mm or at most 13mm or at most 5mm or at most 3mm. The length of the fluid path may be measured at a position where the component is in an initial position relative to the housing or body of the drug delivery device (e.g. before the start of a dose setting operation and/or after the completion of a dose delivery operation). During dose setting, the length may decrease.

According to at least one embodiment, in the transition region, the fluid path comprises at least one coiled or meandering portion, respectively, and/or is a meandering path. For example, in the transition region, the fluid path comprises at least one curved section, for example between two sections extending in different axial directions. In the transition region, the fluid path may include two or more convolutions or serpentine portions. Thus, the fluid path may be formed as a labyrinth path in the transition region.

It may be advantageous to form the transition region such that a gap or space is formed between the facing surfaces of the two elements, for example when relative movement between the elements defining the transition region is desired. The transition region is designed such that the fluid path through which the fluid may reach the interior of the component has at least two sections extending in different axial directions and/or at least one coiled portion in the transition region, reducing the likelihood that the fluid will travel virtually the entire distance along the fluid path.

According to at least one embodiment, the component is configured to move axially and/or rotationally relative to at least one element of the arrangement during use of the drug delivery device. Thus, when the component is connected to the arrangement, the component is still movable relative to at least one element of the arrangement. For example, dose dialing and/or drug delivery procedures are associated with such movement.

According to at least one embodiment, the length of the fluid path in the transition region changes during movement of the component, for example by at least 5% or at least 10%. In particular, a transition region is formed between at least one element of the component and at least one element of the arrangement, wherein the element of the component is movable relative to the element of the arrangement. Thus, the surfaces of the elements forming the transition region therebetween move relative to each other during movement of the components.

For example, during movement of the component, a section of the fluid path in the transition region that extends in the axial direction changes its length, for example its length doubles or its length halves. The length of the sections extending in different axial directions within the transition region may remain constant during movement or may also vary, for example doubling or halving its length.

According to at least one embodiment, a transition region is formed between the component and the elements of both the arrangement. A transition region in the form of a fluid path transition region may be formed between the arrangement and elements of the component, particularly if the elements are movable relative to each other when the component is connected to the arrangement.

The at least one element of the component and the at least one element of the arrangement defining the transition region or a part thereof may be housing elements, i.e. elements delimiting the component or the arrangement, respectively, in one direction (e.g. in an outward radial direction and/or in an axial direction). For example, the element of the arrangement is a housing element. The element of the component may be a gripping element. In particular, the elements of the arrangement and the elements of the component forming at least part of the transition region therebetween may each form an outer surface of the drug delivery device that is touchable by a user.

According to at least one embodiment, a transition region is formed between the distal section of the element of the component and the proximal section of the arranged element. The distal section may extend in a distal direction from the remainder of the element and/or may define a distal end of the element. Thus, the proximal section may extend in a proximal direction from the rest of the element and/or define a proximal end of the element.

According to at least one embodiment, the distal section of the element of the component and the proximal section of the element of the arrangement axially overlap and/or radially deviate from each other when the component is connected to the arrangement. The distal section and the proximal section may also overlap in the angular direction. The distal section of the element of the component may be offset in a radially inward direction, for example, relative to the proximal section of the element of the arrangement.

The functional element may be offset from the distal section of the element in the proximal direction.

According to at least one embodiment, a transition region is formed between at least three elements. The first section of the transition region may be formed between the first element and the second element, and the second section of the transition region may be formed between the second element and the third element. For example, the second element is radially arranged between the first element and the third element. The second element may axially and/or rotationally overlap the first element and/or the third element. For example, the arrangement comprises a first element and a third element, and the component comprises a second element. The second element may be an element comprising a distal section. The first element may be an element comprising a proximal section. The first and second elements may be housing elements. A fluid path transition region comprising a fluid path having two sections extending in opposite axial directions may extend between the three elements.

According to at least one embodiment, the transition region is at a tight transition region, wherein the facing surfaces mate tightly with each other such that no fluid can pass through the transition region. For example, in the transition region, the surfaces are in contact with each other (i.e. at a distance of zero) and/or the distance between the surfaces is at most 0.5mm or at most 0.1mm or at most 0.05mm, so that the transition region is tight. Such a tight transition region may be achieved by an interference fit between the elements providing surfaces facing each other. Preferably, pressure is generated, for example, between two elements having surfaces that fit together by an interference fit. Thus, the transition region can withstand conventional fluid pressures without opening a large gap. Additionally or alternatively, the sealing material may be located in the transition region to make it tight.

By such a tight transition region, fluid can be prevented from passing from the outside to the inside via this transition region.

According to at least one embodiment, the length of the tight transition region measured between the exterior and the interior of the component is at least 1mm or at least 1.5mm or at least 2mm. For example, the tight transition region is tight over its entire length or over at least 20% or at least 50% of its length.

The tight transition region may include a tight sub-region and an imprecise sub-region. In the non-tight sub-areas, the gap between the facing surfaces may be larger than the gap in the tight sub-areas, in particular so large that the fluid may be arranged in the non-tight sub-areas. The strict sub-region may be closer to the outside than the non-strict sub-region, e.g. may abut the outside.

According to at least one embodiment, a snap connection between two elements defining a transition region is formed in the transition region. For example, the snap connection is formed at the end of the transition region, for example at the end closer to the interior of the component. The snap connection may mechanically fix the two elements to each other, for example such that they are not movable relative to each other. The snap connection may be formed by the engagement of a protrusion of one element into a recess of the other element.

According to at least one embodiment, a transition region is formed between elements of the component. For example, the elements of the component may not be movable relative to each other. In particular, in this case, a transition region in the form of a tight transition region can be realized. The element of the component defining the transition region or at least a portion thereof may be a housing element. For example, one of the elements may be a gripping element forming a side surface of the component, and one of the elements may be a cover element forming a proximal surface of the component.

According to at least one embodiment, the functional element is axially and/or radially offset with respect to the transition regions, for example with respect to all transition regions. When the functional element is axially offset relative to the transition region, there may be no overlap between the functional element and the transition region in the axial direction. Similarly, when the functional element is radially offset relative to the transition region, there may be no overlap between the functional element and the transition region in the radial direction. Similarly, when the functional element is axially and radially offset relative to the transition region, there may be no overlap between the functional element and the transition region in the axial and radial directions. In this case, "no overlap" may mean that any part or portion of the functional element does not overlap any part or portion of the transition region in the respective direction.

According to at least one embodiment, at least two transition regions are formed at least when the component is connected to the arrangement. For example, one transition region is formed by elements of both the arrangement and the component. Additional transition regions may be formed between the elements of the component.

According to at least one embodiment, the at least one transition region is a fluid path transition region as indicated above, and the at least one transition region is a strict transition region as indicated above. For example, the fluid path transition region is disposed distally relative to the tight transition region. A tight transition region may be formed at the proximal end of the member. A fluid path transition region may be formed at the distal end of the member.

According to at least one embodiment, the functional element is arranged axially between the fluid path transition region and the tight transition region. For example, the functional element does not axially overlap with either the fluid path transition region or the tight transition region.

According to at least one embodiment, the surface of the component near the transition region is formed of a hydrophobic material. For example, the surface of the component defining the transition region (i.e., adjoining the transition region) is formed of a hydrophobic material. The component may include a coating of hydrophobic material forming the surface.

The use of a hydrophobic surface in or near the transition region may also reduce the risk of fluid reaching the interior via the transition region. By "nearby" is meant, for example, that the hydrophobic surface is at most 1mm or at most 0.5mm from the transition region. The hydrophobic surface may also be the outer surface of the component and/or the arrangement.

According to at least one embodiment, the functional element is associated with an electrical or electronic function of the component. In particular, the component may comprise one or more electrical or electronic elements, and may have an electrical or electronic function. The at least one functional element may be an electrical element. For example, the component may be configured to measure a drug dose delivered during use of the drug delivery device. The component may also be configured to communicate the measured dose to an external device, such as a smartphone or computer, for example, via a bluetooth connection. For this purpose, the component may comprise a wireless communication interface, i.e. a bluetooth interface. Additionally or alternatively, the component may include a user communication electrical or electronic element (such as one or more LEDs) to audibly and/or visually communicate the status of the drug delivery device to the user.

According to at least one embodiment, the functional element is a sensor, such as an optical sensor, or an electromechanical switch or a circuit board or a battery or an LED. The component may comprise one or more or all of the mentioned functional elements. The optical sensor may include an LED (e.g., an infrared LED) and a sensor element configured to detect a reflected portion of light emitted by the LED. In particular, the sensor may be configured to detect relative movement, in particular relative rotation, between the sensor and a further element (e.g. an element of the arrangement). For example, the sensor is a sensor for reading gray codes.

According to at least one embodiment, the component is a user interface member configured to be touched by a user to operate the user interface member when the user interface member is connected to the arrangement. In particular, the component may be a knob or button which is permanently connected or connectable or releasably connectable to the arrangement. The user interface member may be configured to perform dose dialing and/or drug delivery when connected to the arrangement and operated by a user.

For example, the user interface member includes a side surface that forms an outer surface of the component and is configured to be gripped by a user. The side surface may define the user interface member in an outward radial direction. In particular, the side surfaces may extend parallel or at an acute angle to the longitudinal axis.

The side surface may be configured to be gripped by a user with two fingers to perform a rotation of the user interface member about the longitudinal axis, for example a rotation of the housing element relative to the arrangement. Additionally or alternatively, the user interface member may comprise a proximal surface facing in a proximal direction. The proximal surface may extend perpendicularly or obliquely with respect to the longitudinal axis and/or the side surface. The proximal surface may be configured to be touched by a user, for example with only one finger, in particular for pushing the user interface member in the distal direction.

According to at least one embodiment, the side surface may comprise gripping features, such as grooves. The grooves may extend parallel to the longitudinal axis or at an acute angle. The grip feature may simplify the user's grip on the user interface member.

Next, the drug delivery device will be described in detail. The drug delivery device may be an injection device and/or a pen-type device, such as a dial extension (dial extension) pen. The drug delivery device may be a variable dose device, wherein the dose of drug to be delivered to the user may be variably set. For example, the drug delivery device is a reusable device. The drug delivery device may be configured to perform several drug delivery procedures one after the other. For example, during each such drug delivery procedure, a dialed or set dose is delivered to the user.

According to at least one embodiment, the drug delivery device comprises the components as detailed above. Thus, all features disclosed for this component are also disclosed for the drug delivery device and vice versa.

According to at least one embodiment, a drug delivery device comprises an arrangement with a container holder for holding a drug container. The container holder may be a housing element of the arrangement or may be connected or connectable to a housing element. The container holder may be configured to fixedly hold the drug container in an axial direction and/or in a rotational sense with respect to the arranged housing element. In particular, the container holder may hold the drug container such that the drug container does not move in an axial and/or rotational direction during the drug delivery process.

According to at least one embodiment, the component is a user interface member configured to be operated by a user to perform a dose dialing and/or dose delivery procedure.

According to at least one embodiment, the component is configured to rotate and/or axially move relative to the container holder when operated by a user.

According to at least one embodiment, a drug delivery device comprises a drug container filled with a drug. The medicament container may be a syringe having a needle pre-mounted at the distal end. Alternatively, the needle may be attached to the drug container, for example to its distal end.

A method for operating a drug delivery device may be as follows: the user grips the component in the form of a user interface member (e.g. a knob) and connected to the arrangement, e.g. at a side surface, and rotates, thereby dialing or setting a dose to be injected to the user. The user interface member may rotate in a helical path relative to the housing and/or the medicament container (holder), thereby moving e.g. in a proximal direction. After the desired dose has been dialed, the user interface member may be pushed in an axial direction (e.g. in a distal direction) and a drug dose injected. For this purpose, the user may press on the proximal surface of the user interface member. During movement of the user interface member in the distal direction, the user interface member may not rotate, but the movable element of the arrangement (e.g. the element of the dose setting and/or drive mechanism of the device) may rotate. Thereby, the dialed dose may be ejected, e.g. injected into the patient. A sensor in the user interface member may measure the rotation of the movable element. The measurement signal of the sensor may then be sent to an electrical element (e.g. a processor) of the user interface member, which may determine the delivered dose from the measurement signal. This information may then be communicated to another device, for example with the aid of a wireless communication module.

Features disclosed in connection with the method are also applicable to the component and the device and vice versa.

Hereinafter, the components and the drug delivery device described herein will be explained in more detail with reference to the drawings based on exemplary embodiments. Like reference symbols in the various drawings indicate like elements. However, the dimensional proportions referred to are not necessarily to scale, and individual elements may be shown in exaggerated size for better understanding.

Drawings

Figure 1 shows an exploded view of an exemplary embodiment of a drug delivery device,

Fig. 2 and 3 show the proximal section of an exemplary embodiment of a drug delivery device in different views.

Fig. 4 shows the dose setting situation of the device.

Fig. 5 illustrates additional fluid paths in the devices of fig. 1-4.

Detailed Description

Hereinafter, exemplary embodiments will be described with respect to an insulin injection device. However, the present disclosure is not limited to this application and may equally be used with injection devices or drug delivery devices in general, preferably pen-type devices and/or injection devices configured to eject other medicaments.

Furthermore, in the following, exemplary embodiments will be described, wherein the component is a user interface member configured to be operated by a user for dose setting and/or dose injection. However, the present disclosure is not limited to components in the form of user interface members. Rather, the component may also be a module that is connected or connectable to an arrangement of drug delivery devices, for example for measuring a dialled dose, but that is not foreseen to be operated or moved by a user.

Certain exemplary embodiments herein are presented for a drug delivery device in the form of an injection device, wherein the component in the form of a user interface member is a knob implementing both an injection button and a dose setting (dial) member, e.g. similar to the device disclosed in WO 2014/033195 A1 or WO 2014/033197A1 (the disclosures of these documents are expressly incorporated herein by reference, in particular as long as the electronic function and the operation of the dose setting and/or drive mechanism are concerned). Thus, the knob may be used to initiate and/or perform a dose delivery operation of the drug delivery device, and may also be used to initiate and/or perform a dose setting operation. These devices may be of the dial-on elongate type, i.e. their length increases during dose setting. Other injection devices having the same movement behaviour of the dial extension during dose setting and dose expelling modes of operation are known, e.g. sold by the company Eli LillyOrDevice and method for manufacturing the same OrAnd (3) a device. Therefore, it is straightforward to apply the general principles to these devices, and further explanation will be omitted. However, the general principles of the present disclosure are not limited to such athletic activity.

It is conceivable to apply certain other embodiments to injection devices where there is a separate injection button and gripping member/dose setting member, such as the device disclosed in WO 2004/078239 A1. Thus, the present disclosure also relates to a system with two separate user interface members, e.g. one for dose setting operations and one for dose delivery operations. To switch between a dose setting configuration and a dose delivery configuration of the device, the user interface member for dose delivery may be moved relative to the user interface member for dose setting.

If a user interface member is provided, the user interface member may be moved distally relative to the housing element. During a corresponding movement, the clutch between the two elements of the dose setting mechanism and the drive mechanism of the device changes its state, e.g. from engaged to released or vice versa. The two elements may be rotationally locked to each other when a clutch (e.g., a clutch formed by sets of meshing teeth on the two elements) is engaged, and may be allowed to rotate relative to one another when the clutch is disengaged or released. One of these elements may be a drive element or a drive sleeve which engages the plunger rod of the dose setting and driving mechanism. The drive sleeve may be designed to rotate relative to the housing element during dose setting and may be locked in a rotational sense relative to the housing element during dose delivery. The engagement between the drive sleeve and the plunger rod may be a threaded engagement. Thus, because the drive sleeve cannot rotate during dose delivery, axial movement of the drive sleeve relative to the housing element will cause the plunger rod to rotate. During the delivery operation, such rotation may be translated into an axial displacement of the plunger rod by a threaded coupling between the plunger rod and the housing element.

Fig. 1 is an exploded view of an exemplary embodiment of a drug delivery device 100. In this exemplary embodiment, the drug delivery device 100 is an injection device, such as a pen-type injector.

The injection device 100 of fig. 1 is an injection pen comprising a housing element 10 holding a medicament container 14 (e.g. an insulin container) or a container holder for such a container 14. The container 14 may contain a medicament, such as insulin. The container 14 may be a cartridge or a receptacle for a cartridge that may house a cartridge or be configured to receive a cartridge. The needle 15 may be attached to the container 14 or to the receptacle. The container 14 may be a cartridge and the receptacle may be a cartridge holder. The needle 15 is protected by an inner needle cap 16, an outer needle cap 17 or another cap 18. By turning the user interface member 2 in the form of a knob 2, it is possible to set, program or "dial in" the insulin dose to be ejected from the injection device 100 and then display the currently programmed or set dose via the dose window 13, for example in a plurality of units. The unit may be determined by a dose setting mechanism which may allow the knob 2 to be rotated with respect to the housing element 10 by only an integer multiple of one unit setting increment, which may define one dose increment. This may be achieved by, for example, a suitable ratchet system. The indicia displayed in the window may be provided on a number sleeve (number sleeve) or a dial sleeve 70. For example, where the injection device 100 is configured to administer human insulin, the dose may be displayed in so-called International Units (IU), where one IU is a bioequivalence of about 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units may be employed in an injection device for delivering simulated insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than shown in the dose window 13 in fig. 1.

The dose window 13 may be in the form of an aperture in the housing element 10, which allows a user to view a limited portion of the dial sleeve 70 that is configured to move when the knob 2 is turned to provide a visual indication of the currently programmed dose. When turned during programming, the knob 2 rotates in a helical path relative to the housing element 10.

In this exemplary embodiment, the knob 2 includes one or more features 71a, 71b, 71c in the form of formations to facilitate gripping and/or attachment of the data collection device or electronic system.

The injection device 100 may be configured such that turning the knob 2 creates a mechanical click to provide acoustic feedback to the user. In this embodiment, the knob 2 also acts as an injection button. When the needle 15 penetrates into the skin portion of the patient and then the knob 2 is pushed in the axial direction, the insulin dose displayed in the display window 13 will be ejected from the injection device 100. The dose is injected into the patient when the needle 15 of the injection device 100 remains in the skin portion for a certain time after the knob 2 is pushed back in place. Ejection of the insulin dose may also produce a mechanical click, however this is different from the sound produced when the knob 2 is rotated during dialing of the dose.

In this exemplary embodiment, during delivery of an insulin dose, the knob 2 is moved axially back to its initial position without rotation, while the dial sleeve 70 or number sleeve 70 is rotated back to its initial position to, for example, display a zero unit dose. As noted above, the present disclosure is not limited to insulin, but rather should encompass all medications, particularly liquid medications or pharmaceutical preparations, in the medication container 14.

The injection device 100 may be used for several injection procedures until the insulin container 14 is empty or until the expiration date of the medicament in the injection device 100 is reached (e.g. 28 days after the first use).

Furthermore, before the first use of the injection device 100, it may be necessary to perform a so-called "initial injection" to ensure a correct flow of fluid from the insulin container 14 and the needle 15, for example by: while holding the injection device 100 with the needle 15 up, two units of insulin are selected and the knob 2 is pressed. For simplicity of description, in the following it will be assumed that the ejection amount substantially corresponds to the injected dose, such that for example the amount of medicament ejected from the injection device 100 is equal to the dose received by the user.

As explained above, the knob 2 also acts as an injection button such that the same component is used for dialing/setting a dose and dispensing/delivering a dose. Also, it should be noted that a configuration with two different user interface members is also possible, which preferably can only be moved relative to each other in a limited manner. However, the discussion below will focus on a single user interface member providing both dose setting and dose delivery functions. In other words, the setting surface of the member touched by the user for a dose setting operation and the dose delivery surface touched by the user for a dose delivery operation are immovably connected. Alternatively, where different user interface members are used, they may be moved relative to each other. The user interface member is preferably moved relative to the body or housing of the device during the respective operation. During dose setting, the user interface member is moved and/or rotated proximally relative to the housing. During dose delivery, the user interface member is moved axially, e.g. distally, preferably not rotated relative to the housing or body.

Fig. 1 also shows a coordinate system used herein to designate the location of a component or element or feature. The distal direction D and the proximal direction P extend parallel to the longitudinal axis L. The longitudinal axis L is the main extension axis of the device 100. The radial direction R is a direction perpendicular to and intersecting the longitudinal axis L. Azimuthal direction C, also referred to as angular direction or rotational direction, is a direction perpendicular to radial direction R and longitudinal axis L. To improve clarity of the drawings, different directions and axes will not be shown in each of the following drawings.

Fig. 2 shows a proximal section of the drug delivery device 100 of fig. 1 in a cross-sectional view. Fig. 3 shows the same proximal section in different cross-sectional views. As can be seen, a component 2 in the form of a knob 2 is connected to the arrangement 1, wherein the arrangement 1 comprises the above-mentioned housing element 10. The knob 2 may be permanently or releasably connected to the arrangement 1.

In addition to the housing element 10, the arrangement 1 comprises a plunger rod 11a, a drive sleeve 11b and a dial sleeve 11c. These elements are operably coupled for dose dialing and dose injection. For example, during a dose injection, the dial sleeve 11c rotates with the number sleeve 70. This rotation is detected by an optical sensor 21 in the interior of the knob 2, which knob is not rotated during dose injection.

In addition to the optical sensor 21, the knob 2 comprises further functional elements in its interior, namely a circuit board 22, an electromechanical switch 23, a battery 24, one or more LEDs 25 and/or a processor 28. The circuit board 22 may be electrically connected to the optical sensor 21 to receive measurement signals of the sensor 21 and/or to provide power to the sensor 21, and the circuit board 22 may be conductively connected to the processor. The battery 24 may be used to power the sensor 21, the LEDs 25, and/or additional electrical or electronic components (e.g., the processor 28) on the circuit board 22. The mechanical switch 23 may be operated by the drive sleeve 11b when the knob 2 is axially moved (e.g. distally moved) relative to the drive sleeve 11 b. Operation of the mechanical switch 23 may cause energization of the sensor 21 and/or the LED 25. LED 25 may be configured to communicate the operational status of drug delivery device 100 to a user. For this purpose, the cover element 27 forming the proximal surface of the knob 2 may comprise a transparent area through which the light of the LED 25 may exit the knob 2. A transparent region is formed, for example, between a side surface of the knob 2 and a proximal surface of the knob 2.

The functional elements 21 to 25 in the interior of the knob 2 may be damaged or at least affected by the fluid flowing from the exterior of the knob 2 into the interior, in particular because these elements are associated with electrical or electronic functions. In fact, for the knob 2 shown in fig. 2 and 3, fluid may reach the interior and possibly the functional elements 21 to 25 via the transition areas 3, which are formed between facing surfaces of the individual elements of the drug delivery device 100.

One such transition region 3 is formed between an element of the arrangement 1 and a housing element 20 in the form of a gripping element 20 of the knob 2. More precisely, the transition regions 3 are formed between the distal section of the gripping element 20 protruding in the distal direction D and the proximal section of the housing element 10 of the arrangement 1 protruding in the proximal direction P, and between the distal section of the gripping element 20 and the proximal section of the dial sleeve 11 c. The distal section of the gripping element 20 is thus arranged radially between the housing element 10 and the dial sleeve 11 c. The transition region 3 between the elements 10, 20, 11c comprises a gap. The fluid path 3a may extend through this gap. Fluid (e.g. water or a drug) may thus reach the interior from the outside of the knob 2 and may reach e.g. the sensor 21. The fluid path 3a is indicated by a dashed line in fig. 2 and 3. A typical width or height of the gap may be 0.25mm.

As can be seen in fig. 2 and 3, within the transition region 3, the fluid path 3a comprises two sections extending in opposite axial directions. The fluid reaching from the outside to the inside must first travel in the distal direction D along a first section of the fluid path 3a, then must pass through a coiled or curved section of the fluid path 3a, respectively, and then must travel in the proximal direction P along a second section of the fluid path 3a, which may be about 10mm in length. In other words, the design of the transition region 3 is such that a meandering fluid path 3a is formed. This reduces the risk that the fluid (e.g. liquid) actually reaches from the outside to the inside up to any one of the functional elements 21 to 25.

At this point, it should be remembered that the knob 2 is axially and preferably rotationally movable with respect to the housing element 10 of the arrangement 1, for example for setting a dose. In order to achieve good portability, a transition region 3 between the housing element 10 and the rotary knob 2 with a sufficiently large gap is preferred. However, this creates a fluid path 3a and potential fluid ingress. However, the special design of the transition region 3 reduces the risk of fluid reaching the interior of the component 2, as will be explained below. When the knob is moved, for example for dose setting in a proximal direction away from the housing element 10, the length of the fluid path is reduced, for example due to the overlap between the skirt of the knob 2 (which may define a coiled or curved section of the fluid path 3 a) and the housing element 10 separating the fluid path sections extending in opposite directions. When a dose has been set, the fluid path may be shorter by about 3mm than when no dose has been set, as the knob has been moved axially away from the housing element. However, the dose-free or zero-dose position of the knob 2 is the standard position of the knob and, thus, advantageously, given a longer fluid path, in the dose-free or zero-dose position of the knob, the device is better protected from fluid travelling into the relevant area. Fig. 4 shows the fluid path 3a when the knob 2 is in a dose setting position, when the knob has been moved in a proximal direction with respect to the housing element 10 for performing a dose setting operation.

Additional fluid paths are highlighted in fig. 5, for example from outside the device to the switch 23 (path 3d, e.g. about 13 mm) or towards the processor 28 or a compartment within the knob where the processor 28 is arranged (path 3e, e.g. about 12 mm). The processor 28 may be arranged on the same circuit board as the sensor 21 or on a separate circuit board. The fluid travelling along path 3d may cause a malfunction of the switch, such as a short circuit. The travel of fluid along path 3e may impair the function of the processor, or of other elements or components in the compartment.

When the knob 2 is moved axially relative to the housing element 10, the surfaces of the elements 20, 10, 11c (forming the transition region 3 therebetween) are also displaced axially relative to each other. Thereby, the length of the axially extending section of the fluid path 3a also changes. In particular, the section of the fluid path 3a extending in the proximal direction P and more radially inwards changes its length.

In fig. 2 and 3, a further transition region 3 is formed at the proximal end of the knob 2, i.e. between the cover element 27 and the gripping element 20 of the knob 2. The two elements 20, 27 are not movable relative to each other. The transition region 3 between the two elements 20, 27 may thus be formed to be tight, for example a minimum or maximum distance between the surfaces of the two elements 20, 27 facing each other, for example less than 0.05mm. In this way, fluid can be completely prevented from entering the interior from the outside via this transition region 3. For example, the length of this transition region may be about 2mm.

As can be seen from fig. 2 and 3, the tight transition region 3 at the proximal end of the knob 2 comprises one or more tight subregions 3b, and for example, an imprecise subregion 3c is arranged axially between the tight subregions 3b, in which the distance/gap between the two elements 20, 27 is greater. The snap connection 26 between the elements 20, 27 abuts the tight sub-area 3b closer to the interior of the knob 2. The snap-fit connection 26 mechanically connects and secures the elements 20, 27 to each other by an interference fit.

As can be seen in fig. 2 and 3, some functional elements, in particular the optical sensor 21 and the electromechanical switch 23, are axially arranged between the transition region 3 forming the fluid path 3a and the tight transition region 3 at the proximal end of the knob 2. In particular, the functional element is axially spaced from the transition region 3 such that the likelihood of fluid reaching the functional element is further reduced.

In the exemplary embodiment of fig. 2 and 3, the surfaces of the elements defining the transition region 3 and/or the surfaces in the vicinity of the transition region 3 may additionally or alternatively be formed of a hydrophobic material to further reduce the risk of fluid entering through this transition region 3. The hydrophobic material may be a fluoropolymer-based material and/or a material comprising or consisting of PTFE (polytetrafluoroethylene). The hydrophobic material may be or include materials sold as Electrolube TCTF, 3M Novec 1700, or Acota Certonal FC-742.

The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical formulation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or agents are used to treat, cure, prevent or diagnose diseases or to otherwise enhance physical or mental well-being. The medicament or agent may be used for a limited duration or periodically for chronic disorders.

As described below, the drug or medicament may include at least one API in different types of formulations or combinations thereof for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNAs (sirnas), ribozymes, genes, and oligonucleotides. The nucleic acid may be incorporated into a molecular delivery system (such as a vector, plasmid, or liposome). Mixtures of one or more drugs are also contemplated.

The medicament or agent may be contained in a primary package or "medicament container" suitable for use with a medicament delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other sturdy or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about 1 month to about 2 years. Can be stored at room temperature (e.g., about 20 ℃) or at refrigeration temperatures (e.g., about-4 ℃ to about 4 ℃). In some cases, the drug container may be or include a dual chamber cartridge configured to separately store two or more components of the pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow a user to mix the two components as desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are dispensed into a human or animal body.

The drugs or agents contained in the drug delivery devices as described herein may be used to treat and/or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Further examples of disorders are Acute Coronary Syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are examples as described in the following manual: such as Rote list 2014 (e.g., without limitation, main group 12 (antidiabetic agent) or 86 (oncology agent)) and Merck Index (Merck Index), 15 th edition.

Examples of APIs for the treatment and/or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or a human insulin analog or derivative); a glucagon-like peptide (GLP-1), a GLP-1 analogue or GLP-1 receptor agonist, or an analogue or derivative thereof; a dipeptidyl peptidase-4 (DPP 4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof; or any mixture of the above. As used herein, the terms "analog" and "derivative" refer to polypeptides having a molecular structure that may be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and/or exchange of at least one amino acid residue present in the naturally occurring peptide and/or by addition of at least one amino acid residue. The amino acid residues added and/or exchanged may be encodable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also known as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure that may be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) in which one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in a naturally occurring peptide may have been deleted and/or replaced with other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to a naturally occurring peptide.

Examples of insulin analogues are Gly (a 21), arg (B31), arg (B32) human insulin (insulin glargine); lys (B3), glu (B29) human insulin (insulin glulisine); lys (B28), pro (B29) human insulin (lispro); asp (B28) human insulin (insulin aspart); human insulin, wherein the proline at position B28 is replaced with Asp, lys, leu, val or Ala and wherein the Lys at position B29 can be replaced with Pro; ala (B26) human insulin; des (B28-B30) human insulin; des (B27) human insulin and Des (B30) human insulin.

Examples of insulin derivatives are e.g. B29-N-myristoyl-des (B30) human insulin, lys (B29) (N-tetradecoyl) -des (B30) human insulin (insulin detete,) ; B29-N-palmitoyl-des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB 28ProB29 human insulin; B30-N-myristoyl-ThrB 29LysB30 human insulin; B30-N-palmitoyl-ThrB 29LysB30 human insulin; B29-N- (N-palmitoyl-gamma-glutamyl) -des (B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des (B30) human insulin (Degu-insulin (insulin degludec))) ; B29-N- (N-lithocholyl- γ -glutamyl) -des (B30) human insulin; B29-N- (omega-carboxyheptadecanoyl) -des (B30) human insulin and B29-N- (omega-carboxyheptadecanoyl) human insulin.

Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatideExendin-4,39 Amino acid peptides produced by the salivary glands of Ji Ladu exendin (Gila monster), liraglutideSoxhlet Ma Lutai (Semaglutide), tasilu peptide (Taspoglutide), abirudin peptide (Albiglutide)Du Lau peptide (Dulaglutide)RExendin-4, CJC-1134-PC, PB-1023, TTP-054, langla peptide (LANGLENATIDE)/HM-11260C (Ai Pi, peptide (Efpeglenatide))、HM-15211、CM-3、GLP-1Eligen、ORMD-0901、NN-9423、NN-9709、NN-9924、NN-9926、NN-9927、Nodexen、Viador-GLP-1、CVX-096、ZYOG-1、ZYD-1、GSK-2374697、DA-3091、MAR-701、MAR709、ZP-2929、ZP-3022、ZP-DI-70、TT-401(Pegapamodtide)、BHM-034.MOD-6030、CAM-2036、DA-15864、ARI-2651、ARI-2255、, tenipagin (LY 3298176), badopeptide (Bamadutide) (SAR 425899), exenatide-XTEN and glucagon-Xten.

Examples of oligonucleotides are, for example: sodium milbemexCholesterol reducing antisense therapeutic agent for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.

Examples of DPP4 inhibitors are linagliptin (LINAGLIPTIN), vildagliptin, sitagliptin, dilagliptin (DENAGLIPTIN), saxagliptin, berberine.

Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists such as gonadotrophin (follitropin, luteinizing hormone, chorionic gonadotrophin, tocopheromone), somatotropin (Somatropine) (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

Examples of polysaccharides include glycosaminoglycans (glucosaminoglycane), hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and/or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20Sodium hyaluronate.

As used herein, the term "antibody" refers to an immunoglobulin molecule or antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigen. The antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to an Fc receptor. For example, an antibody may be an isotype or subtype, an antibody fragment or mutant that does not support binding to Fc receptors, e.g., its Fc receptor binding region has been mutagenized or deleted. The term "antibody" also includes Tetravalent Bispecific Tandem Immunoglobulin (TBTI) -based antigen binding molecules and/or double variable region antibody-like binding proteins with cross-binding region orientation (CODV).

The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and/or light chain polypeptide) derived from an antibody polypeptide molecule that does not comprise a full-length antibody polypeptide, but still comprises at least a portion of a full-length antibody polypeptide capable of binding an antigen. An antibody fragment may comprise a cleavage portion of a full-length antibody polypeptide, although the term is not limited to such a cleavage fragment. Antibody fragments useful in the present invention include, for example, fab fragments, F (ab') 2 fragments, scFv (single chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small Modular Immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies comprising VHH. Additional examples of antigen-binding antibody fragments are known in the art.

The term "complementarity determining region" or "CDR" refers to a short polypeptide sequence within the variable regions of both heavy and light chain polypeptides, which is primarily responsible for mediating specific antigen recognition. The term "framework region" refers to an amino acid sequence within the variable region of both a heavy chain polypeptide and a light chain polypeptide that is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework regions are not themselves typically directly involved in antigen binding, as known in the art, certain residues within the framework regions of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDRs to interact with an antigen.

Examples of antibodies are anti-PCSK-9 mAb (e.g., aliskirab (Alirocumab)), anti-IL-6 mAb (e.g., sarilumab) and anti-IL-4 mAb (e.g., dolapruzumab (Dupilumab)).

It is also contemplated that a pharmaceutically acceptable salt of any of the APIs described herein is for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

It will be appreciated by those skilled in the art that modifications (additions and/or deletions) may be made to the different components, formulations, instruments, methods, systems and embodiments of the API described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

An example drug delivery device may involve a needle-based injection system as described in ISO 11608-1:2014 (E) section 5.2, table 1. Needle-based injection systems can be broadly divided into multi-dose container systems and single-dose (partially or fully empty) container systems, as described in ISO 11608-1:2014 (E). The container may be a replaceable container or an integral non-replaceable container.

As further described in ISO 11608-1:2014 (E), the multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container contains a plurality of doses, which may be of fixed or variable size (preset by the user). Another multi-dose container system may involve a needle-based injection device with an integral non-replaceable container. In such a system, each container contains a plurality of doses, which may be of fixed or variable size (preset by the user).

As further described in ISO 11608-1:2014 (E), single dose container systems may involve needle-based injection devices with replaceable containers. In one example of such a system, each container contains a single dose, thereby expelling the entire deliverable volume (completely empty). In further examples, each container contains a single dose, thereby expelling a portion of the deliverable volume (partial emptying). Also as described in ISO 11608-1:2014 (E), single dose container systems may involve needle-based injection devices with integrated non-exchangeable containers. In one example of such a system, each container contains a single dose, thereby expelling the entire deliverable volume (completely empty). In further examples, each container contains a single dose, thereby expelling a portion of the deliverable volume (partial emptying).

The invention described herein is not limited by the description in connection with the exemplary embodiments. Rather, the invention comprises any novel feature and any combination of features, in particular any combination of features in the patent claims, even if said feature or said combination itself is not explicitly stated in the patent claims or in the exemplary embodiments.

Reference numerals

1. Arrangement of

2. Component/user interface member/button/knob

3. Transition region

3A fluid path

3B strict sub-region

3C imprecise subregions

3D fluid path

3E fluid path

10. Drug container holder/housing element

11A plunger rod

11B drive sleeve

11C dial sleeve

13. Dose window

14. Medicine container

15. Needle

16. Inner needle cap

17. Outer needle cap

18. Cap with cap

20. Gripping element

21. Optical sensor

22. Circuit board

23. Electromechanical switch

24. Battery cell

25 LED

26. Buckle connecting piece

27. Cover element

28. Processor and method for controlling the same

70. Dialing sleeve

71A … c structure

100. Drug delivery device

D distal direction

P proximal direction

L longitudinal axis

R radial direction

C azimuth/rotation/angular direction

Claims (18)

1.A component (2) for a drug delivery device (100), the component being configured to be connected to an arrangement (1) of the drug delivery device (100), the component comprising

-At least one functional element (21, …, 25), wherein

Forming a transition region (3) between facing surfaces of elements of the drug delivery device (100), at least when the component (2) is connected to the arrangement (1), at least one of the elements being an element of the component (2),

-The transition region (3) passing from the outside of the component (2) to the inside of the component (2), and

-The transition region (3) is designed such that the risk of fluid passing from the outside to the inside of the component (2) via the transition region (3) is reduced to protect the functional element (21, …, 25).

2. The component (2) according to claim 1, wherein,

-The transition region (3) is a fluid path transition region in which the facing surfaces are spaced apart from each other such that a fluid path (3 a) extends between the surfaces along which fluid can travel, and

-The transition region (3) is designed such that, within the transition region (3), the fluid path (3 a) comprises two sections extending in different axial directions.

3. The component (2) according to claim 2, wherein,

-Within the transition region (3), the fluid path (3 a) comprises at least one coiled portion and/or is a tortuous path.

4. A component (2) according to claim 2 or 3, wherein,

-The component (2) is configured to move axially relative to at least one element of the arrangement (1) during use of the drug delivery device (100), and

-The length of the fluid path (3 a) within the transition region (3) changes during movement of the component (2).

5. The component (2) according to any one of the preceding claims, wherein,

-The transition region (3) is formed between elements of both the component (2) and the arrangement (1).

6. The component (2) according to claim 5, wherein,

-The transition region (3) is formed between a distal section of an element of the component (2) and a proximal section of an element of the arrangement (1), and

-The distal section and the proximal section axially overlap and deviate from each other in radial direction when the component (2) is connected to the arrangement (1).

7. The component (2) according to any one of the preceding claims, wherein,

-The transition region (3) is a tight transition region, wherein the facing surfaces mate tightly with each other such that no fluid can pass through the transition region (3).

8. The component (2) according to any one of the preceding claims, wherein,

-The transition region (3) is formed between elements of the component (2).

9. The component (2) according to any one of the preceding claims, wherein,

-The functional element (21, …, 25) is axially and/or radially offset with respect to the transition region (3).

10. Component (2) according to claims 2 and 7, wherein,

-Forming two transition areas (3) at least when the component (2) is connected to the arrangement (1),

-At least one transition region (3) is a fluid path transition region, and at least one transition region (3) is a tight transition region, and

-The functional element (21, …, 25) is arranged axially between the fluid path transition region and the tight transition region.

11. The component (2) according to any one of the preceding claims, wherein,

-The surface of the component (2) near the transition region (3) is formed of a hydrophobic material.

12. The component (2) according to any one of the preceding claims, wherein,

-The functional element (21, …, 25) is associated with an electronic function of the component (2), and

-The functional element (21, …, 25) is an optical sensor (11) or an electromechanical switch (12) or a circuit board (13) or a battery (14) or an LED (15).

13. Component (2) according to any of the preceding claims, wherein,

-The component (2) is a user interface member configured to be touched by a user when connected to the arrangement (1) to operate the user interface member.

14. A drug delivery device (100) comprising

Component (2) according to any one of the preceding claims,

-An arrangement with a container holder (10) for holding a medicament container.

15. The drug delivery device (100) according to claim 14, wherein,

The component (2) is a user interface member configured to be operated by a user to perform a dose dialing and/or dose delivery procedure,

-The component (2) is configured to rotate and/or axially move relative to the container holder (10) when operated by the user.

16. The component (2) according to any one of claims 1 to 13, wherein the transition region (3) reaches from an outer surface of the component (2) to an inner surface of the component (2).

17. The component (2) according to claim 16, wherein the inner surface abuts the interior of the component (2).

18. The component (2) according to any one of claims 1 to 13, 16 or 17, wherein the transition region (3) is a fluid path transition region, wherein the facing surfaces are spaced apart from each other such that a fluid path (3 a) extends between the surfaces along which fluid can travel.